Microfracture apparatuses and methods

ABSTRACT

Embodiments of apparatuses and methods for microfracture (e.g., forming a plurality of microfractures in a bone to encourage cartilage regeneration).

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/863,554, filed Sep. 24, 2015, now U.S. Pat. No. 10,702,395, issuedJul. 7, 2020, which claims the benefit of priority to U.S. ProvisionalPatent Application No. 62/058,190, filed Oct. 1, 2014, herebyincorporated by reference in their entirety.

BACKGROUND 1. Field of the Invention

The present invention relates generally to orthopedic treatments, moreparticularly, but not by way of limitation, to devices and methods fortreating and/or creating microfractures (e.g., in subchondral bone).

2. Description of Related Art

Examples of treatment methods and apparatuses for creatingmicrofractures in bone are disclosed in (1) J. P. Benthien, et al., Thetreatment of chondral and osteochondral defects of the knee withautologous matrix-induced chondrogenesis (AMIC): method description andrecent developments, Knee Surg Sports Traumatol Arthrosc, August 2011,19(8):1316-1319; (2) Thomas J. Gill, MD, et al., The Treatment ofArticular Cartilage Defects Using the Microfracture Technique, Journalof Orthopaedic & Sports Physical Therapy, October 2006, 36(10):728-738;(3) L. de Girolamo, Treatment of chondral defects of the knee with onestep matrix-assisted technique enhanced by autologous concentrated bonemarrow: In vitro characterisation of mesenchymal stem cells from iliaccrest and subchondral bone, Injury, Int. J. Care Injured 41 (2010)1172-1177; (4) Pub. No. US 2009/0143782; (5) Pub. No. US 2005/0043738;(6) Pub. No. US 2005/0021067; and (7) Pub. No. US 2004/0147932.

SUMMARY

This disclosure includes embodiments of apparatuses, kits, and methodsfor treating and/or creating microfractures in bone (e.g., subchondralbone). At least some of the present embodiments are configured todeliver and/or localize active ingredients or biological responses nearthe microfracture site, such as, for example, growth factor(s),anticoagulant(s), protein(s), medicine(s), and/or the like, using amembrane to enclose, at least partially, the microfracture site.

Some embodiments of the present apparatuses comprise: a guide (e.g.,comprising: a platform having a first side, a second side, and a holeextending through the first and second sides, the first side configuredto receive a membrane; and a guide tube having a first end, a secondend, and a channel extending from the first end to the second end, thefirst end configured to be coupled to the platform such that the hole ofthe platform is in fluid communication with the channel of the guidetube); and an applicator comprising a first end, a second end, and anelongated body extending from the first end to the second end, theelongated body having a length greater than a length of the guide tube,the second end of the applicator configured to push a membrane throughthe guide tube to an application site in a patient. In some embodiments,the first side of the platform includes a recess that is configured toreceive a membrane. In some embodiments, the platform and the guide tubeare unitary. In some embodiments, the first end of the applicatorincludes an enlarged handle. In some embodiments, the first end of theapplicator is configured to be engaged by a machine. In someembodiments, the second end of the applicator includes a resilient tip.In some embodiments, the second end of the applicator has a roundedshape. In some embodiments, the second end of the applicator has atransverse dimension that is larger than a transverse dimension of theelongated body.

Some embodiments of the present surgical guide apparatuses comprise: aplatform having a first side, a second side, and a hole extendingthrough the first and second sides, the first side including a recessthat is configured to receive a membrane; and a guide tube having afirst end, a second end, and a channel extending from the first end tothe second end, the first end configured to be coupled to the platformsuch that the hole of the platform is in fluid communication with thechannel of the guide tube.

Some embodiments of the present apparatuses comprise: a platform for asurgical guide, the platform having a first side, a second side, and ahole extending through the first and second sides, the first sideincluding a recess that is configured to receive a membrane, where theplatform is configured to be coupled to a guide tube. In someembodiments, the first side of the platform has a maximum transversedimension that is at least twice as large as a maximum thickness of theplatform. In some embodiments, the platform has an elongated shape withrounded ends. In some embodiments, the recess is rectangular. In someembodiments, the recess has a maximum depth of 5 millimeter (mm). Insome embodiments, the first end of the guide tube has a first outertransverse dimension and the second end of the guide tube has a secondouter transverse dimension that is smaller than the first transversedimension. In some embodiments, the channel has an inner maximumtransverse dimension of 10 millimeters (mm) at a point located nearerthe second end of the guide tube than the first end.

Some embodiments of the present kits comprise: an embodiment of thepresent platforms having a recess configured to receive a membrane; amembrane disposed in the recess of the platform; a package within whichthe platform and membrane are disposed; and where the platform andmembrane are sterile.

Some embodiments of the present kits comprise: an embodiment of thepresent apparatuses in which the first side of the platform includes arecess configured to receive a membrane; a membrane disposed in therecess of the platform; a package within which the apparatus andmembrane are disposed; where the apparatus is sterile.

Some embodiments of the present methods comprise: pushing a membranethrough a guide tube to cover a microfracture in an articular surface ofa patient with the membrane, where the guide tube extends through thepatient's skin such that a distal end of the guide tube is adjacent themicrofracture as the membrane exits the guide tube. Some embodimentsfurther comprise: providing a platform with a first side, a second side,a hole extending through the first and second sides, where the firstside includes a recess that is configured to receive a membrane, and themembrane is disposed in the recess; and coupling the platform to a guidetube prior to pushing the membrane through the guide tube. In someembodiments, the membrane is at least partially folded as it enters theguide tube and at least partially returns to its pre-folded form at theend of the applicator as the applicator pushes the membrane past thefirst end of the guide tube.

Any embodiment of any of the present apparatuses and methods can consistof or consist essentially of—rather thancomprise/include/contain/have—any of the described steps, elements,and/or features. Thus, in any of the claims, the term “consisting of” or“consisting essentially of” can be substituted for any of the open-endedlinking verbs recited above, in order to change the scope of a givenclaim from what it would otherwise be using the open-ended linking verb.

Details associated with the embodiments described above and others arepresented below.

BRIEF DESCRIPTION OF THE DRAWINGS

The following drawings illustrate by way of example and not limitation.For the sake of brevity and clarity, every feature of a given structureis not always labeled in every figure in which that structure appears.Identical reference numbers do not necessarily indicate an identicalstructure. Rather, the same reference number may be used to indicate asimilar feature or a feature with similar functionality, as maynon-identical reference numbers. The figures are drawn to scale (unlessotherwise noted), meaning the sizes of the depicted elements areaccurate relative to each other for at least the embodiment depicted inthe figures.

FIG. 1A depicts a perspective view of an apparatus for creatingsubchondral bone microfractures having a cannula and a penetrator.

FIG. 1B depicts a cross-sectional view of the apparatus of FIG. 1A.

FIG. 1C depicts a cross-sectional view of an enlarged head of thepenetrator shown in FIG. 1A.

FIG. 1D depicts a cross-sectional view of a first end of the cannulashown in FIG. 1A.

FIG. 2A depicts a perspective view of the apparatus of FIG. 1A, with thepenetrator shown in the cannula.

FIG. 2B depicts a cross-sectional view of the apparatus of FIG. 1A, withthe penetrator shown in the cannula.

FIG. 2C depicts a cross-sectional view of a portion of the apparatus ofFIG. 1A that includes a second end of the cannula and a distal end ofthe penetrator, with the penetrator shown in the cannula.

FIG. 3 depicts a perspective view of a second embodiment of an apparatusfor creating subchondral bone microfractures.

FIGS. 4A and 4B depict perspective views of the apparatus of FIG. 3positioned for use relative to a patient's knee, and are not drawn toscale.

FIG. 5A depicts a perspective view of a first embodiment of the presentapparatus for applying a membrane to an articular surface.

FIG. 5B depicts an enlarged perspective view of a portion of theapparatus of FIG. 5A.

FIG. 6A depicts a perspective view of the apparatus of FIG. 5A shownwith a membrane.

FIG. 6B depicts a perspective view of the apparatus of FIG. 5A shownwith a membrane having been guided through a guide tube by anapplicator.

FIG. 6C depicts a perspective view of the apparatus of FIG. 5A with amembrane expanding for application to a microfracture site after passingthrough the guide tube.

DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

The term “coupled” is defined as connected, although not necessarilydirectly, and not necessarily mechanically; two items that are “coupled”may be unitary with each other. The terms “a” and “an” are defined asone or more unless this disclosure explicitly requires otherwise. Theterm “substantially” is defined as largely but not necessarily whollywhat is specified (and includes what is specified; e.g., substantially90 degrees includes 90 degrees and substantially parallel includesparallel), as understood by a person of ordinary skill in the art. Inany embodiment of the present apparatuses, kits, and methods, the term“substantially” may be substituted with “within [a percentage] of” whatis specified, where the percentage includes 0.1, 1, 5, and/or 10percent.

The terms “comprise” (and any form of comprise, such as “comprises” and“comprising”), “have” (and any form of have, such as “has” and“having”), “include” (and any form of include, such as “includes” and“including”) and “contain” (and any form of contain, such as “contains”and “containing”) are open-ended linking verbs. As a result, anapparatus or kit that “comprises,” “has,” “includes” or “contains” oneor more elements possesses those one or more elements, but is notlimited to possessing only those elements. Likewise, a method that“comprises,” “has,” “includes” or “contains” one or more steps possessesthose one or more steps, but is not limited to possessing only those oneor more steps.

Further, an apparatus, device or system that is configured in a certainway is configured in at least that way, but it can also be configured inother ways than those specifically described.

Referring now to the drawings, and more particularly to FIGS. 1A-2C,shown therein and designed by the reference numeral 10 is one embodimentof an apparatus for creating microfractures in bone (e.g., subchondralbone). In the embodiment shown, apparatus 10 comprises a penetrator 14,a cannula 18, and a handle 22 coupled to cannula 18. In otherembodiments (e.g., as shown in FIG. 3 ), handle 22 may be omitted. Inthe embodiment shown, cannula 18 has a first end 26, a second end 30,and a channel 34 extending between the first end and the second end.Such first and second ends should be understood as the locations of thebeginning and end of the channel. In this embodiment, cannula 18 has aprimary portion 38 and a distal portion 42, with primary portion 38extending between first end 26 and distal portion 42 (e.g., a majorityof the length of the cannula, as in the embodiment shown), and withdistal portion 42 extending between primary portion 38 and second end30. The distal portion can be configured such that a second end of thechannel (at second end 30) is disposed at an angle relative to a firstend of the channel (at first end 26). For example, in the embodimentshown, distal portion 42 is disposed at an angle 46 relative to theprimary portion. In the embodiment shown, angle 46 is between 10 and 30degrees (e.g., 20 degrees). In other embodiments, angle 46 can be anysize that permits apparatus 10 to function as described in thisdisclosure (e.g., angle 46 can be equal to, or between any two of: 0,10, 20, 30, 40, 45, 50, and/or 60 degrees). In other embodiments, angle46 can be greater than 60 degrees (e.g., equal to, or between any twoof: 60, 70, 80, 90, and/or more degrees). As a further example, distalportion 42 can include a curved or hooked shape such that angle 46 iseffectively larger than 90 degrees (e.g., equal to, or between any twoof: 90, 120, 150, 180, and/or 180 degrees).

Primary portion 38 has a transverse dimension 50 (e.g., a diameter, inthe embodiment shown). Penetrator 14 and cannula 18 can comprise anysuitable material that permits the apparatus to function as described inthis disclosure (e.g., and permits the penetrator and the cannula to besterilized). For example, in some embodiments, penetrator 14 comprisesnickel-titanium alloy (e.g., Nitinol), and/or cannula 18 comprisesmetal, such as stainless steel (e.g., a surgical stainless steel).Embodiments of the present cannulas are rigid and configured not to flexor bend during use. In other embodiments, penetrator 14 can comprise abiocompatible metal such as stainless steel (e.g., 316L stainlesssteel).

In the embodiment shown, penetrator 14 has a proximal end 54, anenlarged head 58 adjacent proximal end 54, a primary portion 62, adistal end 66 (e.g., pointed distal end 66, as shown), and a penetrationportion 70 adjacent distal end 66. In this embodiment, penetrationportion 70 has a length 74 that is a minority of the length ofpenetrator 14 between proximal end 54 and distal end 66. In someembodiments, penetrator 14 has a transverse dimension of less than 1.2mm (e.g., between 1 mm and 1.1 mm; less than 1.1 mm, less than 1.05 mm,less than 1 mm; less than, or between any two of, 0.5, 0.6, 0.7, 0.8,0.9, and/or 1 mm). For example, in the embodiment shown, penetrationportion 70 has a circular cross-section with a diameter 78 of between0.7 and 0.8 mm (e.g., 0.78 mm). In some embodiments, penetration portion70 has a circular cross-section with a diameter of between 1 and 1.1 mm(e.g., 1.04 mm). Penetrator 14 is configured to be disposed in channel34 of cannula 18 such that penetrator 14 is movable between a (1)retracted position (e.g., in which distal end 66 of the penetrator doesnot extend beyond second end 30 of the cannula) and (2) an extendedposition in which distal end 66 of the penetrator extends beyond secondend 30 of the cannula by a penetration distance 82. In some embodiments,penetration distance 82 is at least (e.g., greater than) 5 mm (e.g., 7mm, 8 mm, 8-10 mm, more than 10 mm) and/or at least (e.g., greater than)5 times (e.g., greater than, or between any two of: 6, 7, 8, 9, 10, ormore times) a transverse dimension (e.g., diameter) of penetrator 14(e.g., diameter 78 of penetration portion 70). For example, in theembodiment shown, penetration distance 82 is between 8 mm and 10 mm(e.g., 10 mm), which is greater than 12 times diameter 78. In theembodiment shown, diameter 50 of primary portion 38 is larger thandiameter 78 of penetration portion 70. In some embodiments, diameter 50is also less than 1.2 mm (e.g., between 1 mm and 1.1 mm, less than 1.1mm, less than 1.05 mm). In some embodiments, diameter 50 issubstantially equal to diameter 78. In some embodiments, penetrator 14comprises a central wire defining diameter 78 that is encircled orencased by an outer tubing (e.g., metallic tubing, plastic shrink wrap,and/or the like along the length of primary portion 62 to definetransverse dimension 50.

In some embodiments, a coating is disposed on at least penetrationportion 70 of penetrator 14 (the coating may also be disposed on primaryportion 62 of the penetrator). In some embodiments, the coating ishydrophilic. Examples of hydrophilic coatings include Hydro-Silkcoatings available from TUA Systems of Florida (U.S.A.). In someembodiments, the coating comprises silver ions. In some embodiments, thecoating comprises one or more active ingredients configured to elicit orstimulate a biological response in (e.g., bone or cartilage) tissue,such as, for example, growth factor(s), anticoagulant(s), protein(s),and/or the like. Such coatings can be applied as known in the art forthe materials used in particular embodiments.

In the embodiment shown, cannula 18 is configured to provide lateralsupport for penetrator 14, such as to prevent the penetrator frombending or buckling while being driven into the hard subchondral bone.For example, in the embodiment shown, diameter 50 of primary portion 62of the penetrator is nearly as large as (e.g., greater than, or betweenany two of: 95, 96, 97, 98, 99, and or 100 percent of) the diameter ofchannel 34, and diameter 78 of penetration portion 70 is greater than75% (e.g., greater than, or between any two of: 75, 80, 85, 90, 95,and/or 100 percent of) the diameter of channel 34 (e.g., the diameter ofchannel 34 adjacent second end 30 of the cannula). In some embodiments,penetrator 14 is substantially straight prior to being disposed inchannel 34 of cannula 18, such that inserting the penetrator into thecannula causes the penetration portion 70 of the penetrator to be angledrelative to primary portion 62. In some such embodiments, penetrator 14may be resilient enough to (e.g., at least partially) return to itsstraight shape after removal from the cannula.

In some embodiments, penetrator 14 is configured to be moved or advanced(e.g., substantially without rotation of the penetrator) from theretracted position to the extended position (FIG. 2B) to form amicrofracture in subchondral bone (e.g., in a patient's knee or shoulderjoint), the microfracture having a depth of at least (e.g., more than) 5mm (e.g., 7 mm, 8 mm, 8-10 mm, more than 10 mm) and/or at least (e.g.,greater than) 5 times (e.g., greater than, or between any two of: 6, 7,8, 9, 10, or more times) a transverse dimension (e.g., diameter) ofpenetrator 14 (e.g., diameter 78 of penetration portion 70). Forexample, in the embodiment shown, penetrator 14 is configured to bemoved or advanced (e.g., substantially without rotation of thepenetrator, which includes no rotation up to rotation of less than onefull revolution clockwise and/or counterclockwise from the position atwhich distal end 66 of the penetrator first contacts the bone) from theretracted position to the extended position (FIG. 2B) to form amicrofracture in subchondral bone (e.g., in a patient's knee or shoulderjoint), the microfracture having a depth of between 8 mm and 10 mm(e.g., 10 mm), which is greater than 12 times diameter 78. In theembodiment shown, penetrator 14 is configured to be moved or advancedmanually to the extended position. As used in this disclosure, moved oradvanced “manually” means without the assistance of an external energysource other than that provided by a user. For example, if thepenetrator is moved or advanced with a battery-powered or spring-drivendriver, it would not be “manually.” Conversely, the penetrator would bemoved or advanced “manually” if a mallet, hammer, or other tool is swungby a user (e.g., in the user's hand) to impact first end 26 of thepenetrator. In some embodiments, the present apparatuses are configuredsuch that the penetrator can (but need not) be rotated as it is advancedor moved from the retracted position to the advanced position. Forexample, a portion of the penetrator (e.g., enlarged head 58) can bedisposed in the chuck of a drill such that the drill can rotate thepenetrator. In such embodiments, the penetrator may (but need not) besubstantially straight or axial (without bends) along its entire length(e.g., prior to being disposed in a cannula with an angled distalportion).

In the embodiment shown, penetration distance 82 (and the depth of themicrofracture the apparatus is configured to create) is limited byenlarged head 58 contacting the cannula (e.g., penetration distance ismaximized when enlarged head 58 contacts the cannula, as shown in FIG.2B). For example, in the embodiment shown, cannula 18 includes arecessed portion 86 and a shelf 90. As shown, recessed portion 86extends from first end 26 toward second end 30 (inwardly), and shelf 90is disposed between recessed portion 86 and second end 30 such thatpenetration distance 82 is limited by enlarged head 58 contacting shelf90. For example, in the embodiment shown, enlarged head 58 has acylindrical (e.g., circular cylindrical, as shown) with a first end 94and a second end 98, and is configured such that second end 98 contactsshelf 90 when the penetrator is in the extended position relative to thecannula (FIG. 2B). In some embodiments, recessed portion 86 can beconfigured to maintain the orientation or alignment of enlarged head 58as the penetrator is moved or advanced from the retracted position tothe extended position. For example, in some embodiments, recessedportion 58 has a depth 102 that is at least as large as (e.g., isgreater than, or between any two of: 100, 110, 120, 130, 140, 150, ormore percent of) penetration distance 82 (e.g., such that enlarged head58 is at least partially within recessed portion 86 when distal end 66extends beyond second end 30 of the cannula), and/or enlarged head 58has a transverse dimension (e.g., diameter) that is at least 90% (e.g.,greater than, or between any two of: 90, 92, 94, 96, 98, and/or 100percent) of a corresponding transverse dimension of recessed portion 86(e.g., such that cannula 18 limits tilting of enlarged head 58 relativeto cannula 14, and/or limits misalignment of enlarged head 58 relativeto primary portion 62 of the penetrator).

For example, in the embodiment shown, depth 102 of recessed portion 58is between 175% and 250% (e.g., between 200% and 225%) of penetrationdistance 82. In this embodiment, enlarged head 58 and recessed portion86 each has a circular cross section, and enlarged head 58 has adiameter 106 that is between 90% and 100% (e.g., between 95% and 100%)of diameter 110 of recessed portion 86. In some embodiments, a length114 of enlarged head 58 is at least 150% (e.g., at least, or between anytwo of: 150, 175, 200, 225, 250, 300, or more percent) of penetrationdistance 82. For example, in the embodiment shown, length 114 is over300% of penetration distance 82, such that a portion of enlarged head 58that is at least as long as penetration distance 82 is disposed inrecessed portion 86 when distal end 66 of the penetrator is even withsecond end 30 of the cannula (and the orientation of enlarged head 58relative to cannula 18 is thereby maintained). In some embodiments,enlarged head 58 has an elongated shape such that length 114 is greaterthan (e.g., greater than, or between any two of: 2, 3, 4, 6, 8, or moretimes) diameter 106. For example, in the embodiment shown, length 114 isbetween 8 and 12 times diameter 106.

FIG. 3 depicts a second embodiment 10 a of a microfracture apparatus.Apparatus 10 a is substantially similar to apparatus 10, with theexception that apparatus 10 a does not include a handle (e.g., handle22).

Embodiments of microfracture device kits can comprise one or more of thepresent cannulas (e.g., cannula 14) and a reusable tray or othercontainer in a package (e.g., a sealed pouch or the like), where boththe cannula(s) and the tray are or can be sterilized (and can bere-sterilized in advance of being re-used). Both the tray and thepackage may be rectangular in shape. In addition, some embodiments ofmicrofracture device kits can also include two or more penetratorsconfigured to create different microfractures. For example, someembodiments of the microfracture device kits comprise one or more of thepresent cannulas, a sterilizable tray, a first penetrator configured tohave a penetration distance of between 5 mm and 8 mm when used incombination with the cannula, and a second penetrator configured to havea penetration distance greater than 8 mm when used in combination withthe cannula. More specifically, some embodiments of the microfracturedevice kits may include a package (e.g., a box or a flexible package)that comprises sterilized versions of these items. Other embodiments ofthe microfracture device kits comprise one or more of the presentpenetrators (e.g., a single penetrator or two penetrators havingdifferent penetration depths, different tip diameters, different tipshapes, and/or the like) that are sterile and disposed in a package.Embodiments of the microfracture device kits may also include, in morespecific embodiments, instructions for use, which instructions may beinside the package (e.g., as an insert) or outside the package (such asa sticker on the package).

FIGS. 4A and 4B depict an example of microfracture methods (e.g., usingembodiment 10 a of the microfracture apparatuses). Some embodiments ofthese methods comprise: disposing an embodiment of the presentmicrofracture apparatuses (e.g., 10, 10 a) adjacent to subchondral boneof a patient (e.g., in the knee, shoulder, or other joint). For example,in the embodiment shown, apparatus 10 a is disposed adjacent tosubchondral bone of articular surface 150 in a patient's knee 154 (e.g.,with second end 30 of cannula 18 in contact with the subchondral bone,as shown). Some embodiments further comprise moving or advancingpenetrator 14 relative to cannula 18 (e.g., from FIG. 4A to FIG. 4B)until distal end 66 of the penetrator extends into the subchondral bone(as in FIG. 4B) to form a microfracture having a depth of at least 5 mm.For example, in the embodiment shown, penetrator 18 is manually advancedsubstantially without rotation of the penetrator by striking orimpacting proximal end 54 of the penetrator with a mallet 158 untildistal end 66 extends into the subchondral bone by a distance of, andforms a microfracture 162 having a depth of, 10 mm. In the embodimentshown, the position of second end 30 of the cannula relative to thesubchondral bone remains substantially constant while advancing thepenetrator into the bone. In some embodiments of the microfracturemethods, the apparatus is repeatedly disposed adjacent the bone (e.g.,with second end 30 of the cannula in contact with the subchondral boneand/or in contact with cartilage, such as, for example, cartilage aroundthe perimeter of a lesion), and the penetrator is repeatedly advancedinto the subchondral bone to form a plurality of microfractures (e.g.,having substantially the same depths). In some embodiments, themicrofracture methods can be performed on and/or in the surfaces ofother joints, such as, for example, the shoulder, the ankle, the hip,and/or the patellofemoral joint within the knee.

FIGS. 5A and 5B depict an embodiment 500 of the present apparatus fortreating subchondral bone surfaces (e.g., microfractures in an articularsurface of bone). In the embodiment shown, apparatus 500 comprises aguide 504 and an applicator 508. In this embodiment, guide 504 comprisesa platform 512 and a guide tube 516. As shown, platform 512 has a firstside 520, a second side 524, and a hole 528 extending through the firstand second sides. In the depicted embodiment, first side 520 of platform512 includes a recess 532 that is configured to receive a membrane(e.g., 600 in FIG. 6A-6C). In this embodiment, guide tube 516 has afirst end 536, a second end 540, and a channel 544 extending from thefirst end to the second end. As shown, first end 536 of the guide tubeis configured to be coupled to platform 512 such that hole 528 of theplatform is in fluid communication with channel 544 of the guide tube.In the embodiment shown, applicator 508 has a first end 548, a secondend 552, and an elongated body 556 extending from the first end to thesecond end. As shown, body 556 has a length 560 (between first andsecond ends 548, 552) that is greater than a length 564 of the guidetube (between first and second ends 536, 540), and second end 552 of theapplicator is configured to push a membrane (e.g., 600) through theguide tube to an application site (e.g., 604) in a patient.

In the embodiment shown, guide tube 516 is unitary with platform 512. Inother embodiments, the guide tube (e.g., 516) and the platform (e.g.,512) are not unitary, such that, for example, a user can replace theplatform (e.g., if different platforms are needed in a given procedure,such as, for example, for different types of membranes). In someembodiments, the platform (e.g., 512) is preloaded with a membrane(e.g., in a sterile kit or by an assistant aiding a physician in amicrofracture procedure), and/or coupled to the guide tube (e.g., 516)while the membrane is disposed in the recess of the platform. Suchpreloaded embodiments can simplify the use of membranes, which may bedifficult to handle during surgery, and/or may reduce the risk ofinfection by limiting handling of the membrane before it is placed in apatient.

In the embodiment shown, first end 548 of the applicator includes anenlarged handle to assist with manipulation of the applicator. In otherembodiments, the first end of the applicator can be configured to beengaged by a machine. In the embodiment shown, second end 552 of theapplicator has a transverse dimension that is larger than a transversedimension of elongated body 556. As shown, second end of the applicatorcan have a rounded shape. In this embodiment, second end 552 of theapplicator comprises a resilient tip 568. Resilient tip 568 can compriseplastic, polymer, latex, rubber, cotton, gauze, textiles and/or thelike.

In the embodiment shown, first side 520 of the platform has a maximumtransverse dimension that is at least twice as large as a maximumthickness of the platform. As shown, the platform can be an elongatedshape with rounded ends. In some embodiments, the platform geometry canbe varied based on ergonomic considerations; membrane shape, size,and/or type; manufacturing costs; and/or other considerations, such asfor a particular implementation or use. In the embodiment shown, recess532 is rectangular and has a maximum depth of 5 millimeters (mm). Inother embodiments, recess 532 can comprise any shape that is suitable toreceive a membrane for a microfracture site (e.g., square, circular,oval, triangular, and/or the like). For example, in some embodiments,certain microfracture sites may be more-readily accessed and/or treatedwith a membrane that has a circular shape.

In the embodiment shown, channel 544 has an inner maximum transversedimension of 10 mm at a point located nearer second end 540 of the guidetube than first end 536. In this embodiment, first end 536 of guide tube516 has a first outer transverse dimension and second end 540 of theguide tube has a second outer transverse dimension that is smaller thanthe first transverse dimension. In the embodiment shown, for example,adjacent second end 540, the guide tube has an outer diameter of 0.234inch, and an inner diameter of 0.210 inch, which dimensions may differin other embodiments (e.g., 0.234±0.05 inches, and 0.210 0.05 inches).In some embodiments, the guide tube has a variable profile. For example,in the embodiment shown, the guide tube has a first section with asubstantially uniform outer transverse dimension (e.g., diameter, asshown) along a majority of the length of the guide tube 516, and asecond section having a larger and substantially constant outertransverse dimension (e.g., diameter, as shown). In other embodiments,the guide tube can have an outer transverse dimension that tapers alongat least a portion of the length of the guide tube.

In the embodiment shown, apparatus 500 is configured to enablecontrolled and precise placement of membrane 600 at a surgical site. Forexample, placement of a membrane over a microfracture site canfacilitate localization of the biological response created by themicrofractures in tissue (e.g., bone or cartilage), such as, forexample, generation of growth factor(s), anticoagulant(s), protein(s),and/or the like. In some embodiments of the present apparatus, methodsand kits, the membrane can comprise an amniotic membrane such as thePalinGen Flow or PalinGen Membrane available from Amnio Technology LLC.Other human-derived membranes (e.g., human dermal grafts),animal-derived membranes (e.g., animal dermal grafts, and/or therapeuticsynthetic membranes can also be used. In other embodiments, the membranecan comprise other materials (e.g., that localize certain biologicalmaterials around the microfracture site while allowing other biologicalmaterials to leave the microfracture site). The membrane itself may becoated with medication(s), growth factor(s), anticoagulant(s),protein(s), and/or the like.

Some embodiments of the present methods comprise: pushing a membrane(e.g., 600) through a guide tube (e.g., 516) to cover a microfracture inan articular surface of a patient with the membrane. In at least some ofthe present methods, the guide tube can extend through the patient'sskin such that a distal end of the guide tube is adjacent themicrofracture as the membrane exits the guide tube. FIGS. 6A-6C, forexample, illustrate an example of the present method of placing amembrane at a subchondral bone microfracture site 604 in a patient usingapparatus 500. In FIG. 6A, membrane 600 is shown between second ordistal end 552 of applicator 508 and recess 532 of platform 512. Whileshown external to recess 532 for illustration purposes, in at least someembodiments, membrane 600 will be positioned in recess 532 for stabilityand positioning prior to being contacted by applicator 508. End 552 ofapplicator 508 can then be inserted through hole 528 to collapse and/orfold (as membrane 600 wraps around end 552) and push membrane 600 intoand through channel 544.

FIG. 6B shows end 552 of applicator 508 exiting channel 544 of guidetube 516, such that membrane 600 is partially beyond second end 540 butstill held in the collapsed or folded state by guide tube 516. As themembrane exits the end of the guide tube, the membrane can at leastpartially return to its pre-folded or pre-collapsed form. Collapsing orfolding the membrane for delivery through a guide tube allows fordelivery of the membrane to the application site (e.g., 604) through arelatively smaller incision than would be required without guide tube,and/or without exposing the membrane to fluids around the surgical site.

In some embodiments, the present methods further comprise providing aplatform (e.g., 512) with a membrane disposed in a recess (e.g., 532) ofthe platform; and coupling the platform to a guide tube (e.g., 516)prior to pushing the membrane through the guide tube.

Some embodiments of the present kits comprise: a platform (e.g., 520)for a surgical guide and that is configured to be coupled to a guidetube. Some embodiments further comprise, a membrane disposed in a recessof the platform; and a package within which the platform and membraneare disposed; where the platform and membrane are sterile.

Some embodiments of the present kits comprise: an embodiment of thepresent apparatuses (e.g., 500). Some embodiments further comprise amembrane disposed in the recess of the platform. Some embodimentsfurther comprise a package within which the apparatus is disposed wherethe apparatus is sterile.

The above specification and examples provide a complete description ofthe structure and use of exemplary embodiments. Although certainembodiments have been described above with a certain degree ofparticularity, or with reference to one or more individual embodiments,those skilled in the art could make numerous alterations to thedisclosed embodiments without departing from the scope of thisinvention. As such, the various illustrative embodiments of the presentdevices are not intended to be limited to the particular formsdisclosed. Rather, they include all modifications and alternativesfalling within the scope of the claims, and embodiments other than theone shown may include some or all of the features of the depictedembodiment. For example, penetrator 18 and/or channel 34 can have anysuitable cross-sectional shape (e.g., triangular, square, rectangular,and/or the like) that permits the present apparatuses and methods tofunction as described in this disclosure. For example, components may becombined as a unitary structure, and/or connections may be substituted.Further, where appropriate, aspects of any of the examples describedabove may be combined with aspects of any of the other examplesdescribed to form further examples having comparable or differentproperties and addressing the same or different problems. Similarly, itwill be understood that the benefits and advantages described above mayrelate to one embodiment or may relate to several embodiments.

The claims are not intended to include, and should not be interpreted toinclude, means-plus- or step-plus-function limitations, unless such alimitation is explicitly recited in a given claim using the phrase(s)“means for” or “step for,” respectively.

The invention claimed is:
 1. An apparatus comprising: a guidecomprising: a platform having a first side, a second side, and a holeextending through the first and second sides, the first side configuredto receive a membrane; and a guide tube having a first end, a secondend, and a channel extending from the first end to the second end, thefirst end configured to be coupled to the platform such that the hole ofthe platform is in fluid communication with the channel of the guidetube; and an applicator separably couplable to the platform and theguide tube, the applicator comprising a first end, a second end, and anelongated body extending from the first end to the second end, theelongated body having a length greater than a length of the guide tube,the second end of the applicator having a resilient tip for pushing themembrane through the hole and the guide tube to an application site in apatient, wherein the first side of the platform is configured tofacilitate stability and positioning of the membrane prior to contactingthe resilient tip.
 2. The apparatus of claim 1, where the first side ofthe platform includes a recess that is configured to receive themembrane.
 3. The apparatus of claim 1, where the platform and the guidetube are unitary.
 4. The apparatus of claim 1, where the first end ofthe applicator includes an enlarged handle.
 5. The apparatus of claim 1,where the first end of the applicator is configured to be engaged by amachine.
 6. The apparatus of claim 1, where the second end of theapplicator has a rounded shape.
 7. The apparatus of claim 1, where thesecond end of the applicator has a transverse dimension that is largerthan a transverse dimension of the elongated body.
 8. A surgical guideapparatus comprising: a platform having a first side, a recess disposedon the first side, and an unencumbered hole within the recess, such thatthe recess is configured to receive a membrane thereon and cover anentirety of said hole, so as to provide stability and positioning of themembrane prior to being pushed through said hole; and a guide tubehaving a first end, a second end, and a channel extending from the firstend to the second end, the first end configured to be coupled to theplatform such that the hole of the platform is in fluid communicationwith the channel of the guide tube.
 9. The apparatus of claim 8, wherethe first end of the guide tube has a first outer transverse dimensionand the second end of the guide tube has a second outer transversedimension that is smaller than the first transverse dimension.
 10. Theapparatus of claim 8, where the channel has an inner maximum transversedimension of 10 millimeters (mm) at a point located nearer the secondend of the guide tube than the first end.
 11. An apparatus comprising: aplatform for a surgical guide, the platform having a first side, arecess disposed on the first side, and an unencumbered hole within therecess, such that the recess is configured to receive a membrane thereonand cover an entirety of said hole, so as to provide stability andpositioning of the membrane prior to being pushed through said hole,where the platform is configured to be coupled to a guide tube.
 12. Theapparatus of claim 11, where the first side of the platform has amaximum transverse dimension that is at least twice as large as amaximum thickness of the platform.
 13. The apparatus of claim 11, wherethe platform has an elongated shape with rounded ends.
 14. The apparatusof claim 11, where the recess is rectangular.
 15. The apparatus of claim14, where the recess has a maximum depth of 5 millimeter (mm).
 16. A kitcomprising: a platform as recited in claim 11; a membrane disposed inthe recess of the platform; a package within which the platform andmembrane are disposed; and where the platform and membrane are sterile.17. A kit comprising: the apparatus as recited in claim 11; a membranedisposed in the recess of the platform; a package within which theapparatus and membrane are disposed; and where the apparatus is sterile.18. A method comprising: providing a platform having a first side, arecess disposed on the first side, and an unencumbered hole within therecess, such that the recess is configured to receive a membrane thereonand cover an entirety of said hole, so as to provide stability andpositioning of the membrane prior to being pushed through said hole; andpushing a membrane through a guide tube coupled to said platform, tocover a microfracture in an articular surface of a patient with themembrane, where the guide tube extends through the patient's skin suchthat a distal end of the guide tube is adjacent the microfracture as themembrane exits the guide tube.
 19. The method of claim 18, furthercomprising: coupling the platform to the guide tube prior to pushing themembrane through the guide tube.